OncoMatch/Clinical Trials/NCT06411691
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Is NCT06411691 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including KRAS Vaccine with Poly-ICLC adjuvant and Balstilimab for colorectal cancer.
Treatment: KRAS Vaccine with Poly-ICLC adjuvant · Balstilimab · Botensilimab — Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Pancreatic Cancer
Biomarker criteria
Required: KRAS one of the KRAS mutations included in the vaccine
Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor
Required: MMR proficient
MMR-p
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–0(Fully active)
Prior therapy
Must have received: FOLFIRINOX or gemcitabine+nab-paclitaxel (FOLFIRINOX, gemcitabine+nab-paclitaxel) — 1st line metastatic unresectable PDAC
Have received 4-6 months of FOLFIRINOX or gemcitabine+nab-paclitaxel for the 1st line treatment of metastatic unresectable PDAC
Must have received: SOC chemotherapy per NCCN guidelines (FOLFIRINOX, FOLFOX, FOLFIRI +/- targeted therapy with VEGFi or EGFRi) (FOLFIRINOX, FOLFOX, FOLFIRI) — 1st line metastatic CRC
Have received 4-6 months of 1st line SOC chemotherapy per NCCN guidelines (FOLFIRINOX, FOLFOX, FOLFIRI +/- targeted therapy with VEGFi or EGFRi) of metastatic CRC
Must have received: KRAS inhibitor
including prior KRAS inhibitor
Cannot have received: immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4)
Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.)
Lab requirements
Blood counts
adequate organ and marrow function defined by study-specified laboratory tests
Kidney function
adequate organ and marrow function defined by study-specified laboratory tests
Liver function
adequate organ and marrow function defined by study-specified laboratory tests
Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
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